Dako A/S, Genentech Ink Pact on the FDA Regulatory Submissions of Dako’s HercepTest(TM) and HER2 FISH pharmDx(TM) as Companion Diagnostics for Trastuzumab Emtansine (T-DM1)

GLOSTRUP, DENMARK--(Marketwire - May 01, 2012) - Dako, a worldwide provider of cancer diagnostics solutions, has signed an agreement with Genentech, member of the Roche Group, to collaborate on the regulatory submissions of Dako’s HercepTest™ and HER2 FISH pharmDx™ as companion diagnostics for a Genentech investigational drug candidate, trastuzumab emtansine (T-DM1), in patients with advanced HER2-positive breast cancer.

Under the terms of the agreement, Dako and Genentech will collaborate on the regulatory FDA submissions of HercepTest™ and HER2 FISH pharmDx™ to identify cancer patients who may be eligible for treatment with trastuzumab emtansine.

“It is a pleasure to welcome Genentech as a partner once again. Working with Genentech on this FDA submission for companion diagnostics for trastuzumab emtansine is another important step forward in our relentless commitment to fighting cancer,” says Lars Holmkvist, CEO of Dako.

The collaboration on the submission process for HercepTest™ and HER2 FISH pharmDx™ as companion diagnostics for trastuzumab emtansine is in line with Dako’s ongoing strategy to combine its strengths with pharmaceutical companies to grow the offering of Dako’s companion diagnostic assays.

“At Dako we are constantly looking for new opportunities to move pathology forward, and we see this new agreement as a sign of confidence in Dako’s leading competencies within the area of companion diagnostics,” says Lars Holmkvist.

Today’s announcement comes on the heels of a recently announced collaboration between Dako and Genentech on the regulatory submissions of Dako’s HercepTest™ and HER2 FISH pharmDx™ as companion diagnostics for another Genentech investigational drug candidate -- Pertuzumab.

About Dako
Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako’s know-how, reagents, instruments and software to make accurate diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1,000 people and being present in more than 80 countries, Dako covers essentially all of the anatomic pathology markets globally. Dako is owned by private equity fund EQT V. www.dako.com